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Senior Operations Manager
2 months ago
Position Overview
The Senior Operations Manager will be responsible for overseeing the execution of plans, scheduling, and facilitating the visual inspection, labeling, and packaging of pharmaceutical products, including parenteral and dermatological items, to align with sales objectives while adhering to current Good Manufacturing Practices (cGMPs) and established Standard Operating Procedures (SOPs). This role also encompasses the management of the warehouse shipping and receiving team.
Key Responsibilities
- Supervise shift leads and floor personnel through consistent engagement in the inspection and packaging areas, as well as the warehouse, to enhance safety, optimize quality, and boost performance.
- Oversee all kit inspection, packaging, and labeling operations in line with directives from the Operations Director and commercial forecasts.
- Plan, lead, manage, prioritize, and organize tasks within the ILP and warehouse operations teams.
- Collaborate closely with the Senior Production Manager to ensure alignment in packaging area scheduling.
- Act as a Subject Matter Expert (SME) for Visual Inspection during regulatory inspections.
- Delegate daily responsibilities to the team to achieve production targets effectively.
- Ensure that all staff training and qualifications for Visual Inspection are current.
- Address routine and complex inspection and packaging challenges, including equipment issues, promptly with staff and other departments.
- Revise batch records and SOPs as necessary to enhance the efficiency and quality of manufacturing and packaging processes.
- Utilize systems such as SAP, Track-Wise, EDMS, and Master Control.
- Initiate and complete Deviations, Change Control, CAPAs, etc.
- Maintain accurate computer data for the packaging department, documenting production inventory, results, dates, and issues.
- Review all in-process documentation for precision.
- Ensure the proper functioning of Inspection, Labeling, and Packaging equipment.
- Plan and procure supplies for production to guarantee timely achievement of production goals.
- Provide recommendations on efficiency and cost-effectiveness as appropriate.
- Work with minimal supervision, employing standard procedures alongside personal judgment.
- Prioritize safety and uphold cleanliness in the ILP working area and warehouse.
- Oversee all stages of the Change Control process for changes under your purview.
- Recruit, train, manage, and motivate staff to meet production and warehouse requirements.
- Perform additional duties as assigned.
Work Environment:
- Office
- Shop/Shipping area
- Controlled/Manufacturing area
Physical Demands:
- Ability to stand, sit, walk, use hands and fingers for handling or feeling, and reach with hands and arms.
- Capability to climb, balance, stoop, kneel, crouch, or crawl, and communicate effectively.
- Good vision, including close, color, and peripheral vision, depth perception, and the ability to adjust focus.
- Correctable 20/20 vision is required.
- Ability to visually inspect small products and print.
- Capability to multitask effectively.
- Experience operating label application machinery, thermal transfer printers, computers, serialization, and heat sealing equipment.
- Proficient in operating computer and office machines.
- Adhere to proper gowning procedures, including safety shoes, glasses, and gloves.
- Ability to lift up to 30 lbs.
Travel Requirements:
Minimal travel, estimated at up to 5%.
Qualifications:
- Bachelor's degree required.
- Must possess a valid class D Driver's license.
- Ability to operate and maintain all process equipment.
- Familiarity with FDA cGMP, SOPs, and ISO standards.
- Knowledge of pharmaceutical labeling, packaging equipment, and warehouse operations.
Experience:
- 8-10 years of relevant experience, with a minimum of 4-6 years in a supervisory or managerial capacity.
- Direct experience with manual visual inspection for small volume parenteral products is essential.
- Strong computer skills are required.
The anticipated base compensation for this position ranges from $130,000 to $140,000, with a 15% bonus target. Actual compensation may vary based on various factors, including geographical location and experience. This position is also part of the Annual Performance Bonus Plan. Employees are eligible for a range of benefits, including medical, dental, and vision coverage, life insurance, disability insurance, a 401(k) savings plan with company match, flexible spending accounts, and an employee assistance program. Paid time off benefits, including vacation and sick leave, are also provided.
The details provided above are subject to the terms and conditions of applicable plans, policies, practices, agreements, or other documents in effect from time to time, including eligibility criteria. If hired, the employee will be in an at-will position, and the company reserves the right to modify base salary and other discretionary compensation programs at any time, based on individual performance, company performance, and market factors.
This job description is intended to convey the general nature and level of work performed by employees in this classification. It is not designed to be a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this role. The employer reserves the right to modify these duties as necessary.
Sun Pharmaceuticals is committed to providing equal employment opportunities for all employees and applicants. This policy prohibits discrimination based on race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, sexual orientation, military or veteran status, or any other basis prohibited by law.
Notice to Agencies:
Sun Pharmaceuticals is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted by third-party agencies without a valid written and signed search agreement will become the sole property of Sun Pharmaceuticals, and no fee will be paid if a candidate is hired as a result of an unsolicited referral.
